Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis

Chronic Pancreatitis Clinical Trial

Official title:

Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06267365
• Other study ID #: 23-00766
• Status: Recruiting
• Start date: November 27, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: Lisa Doan, MD
• Phone: 212-263-5072
• Email: Lisa.doan[@]nyulangone.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational prospective study to develop predictive biomarkers for pain response in participants with chronic pancreatitis scheduled for endoscopic therapy. Participants will undergo baseline assessments including electroencephalography (EEG), quantitative sensory testing (QST), and psychosocial questionnaires. Response to endoscopic therapy will be assessed at approximately 3, 6, 12 and 18 months post-procedure using questionnaires.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adults older than 18 years;
• Cambridge III or IV criteria for CP; or M-ANNHEIM criteria for definitive chronic pancreatitis;
• scheduled for endoscopic therapy for ductal obstruction (may include lithotripsy, pancreatic duct dilation, or stone extraction to facilitate successful stenting) as part of routine clinical care based on multidisciplinary review;
• pain present for = 3 days per week for = 3 months;
• average pain over the last week = 4 on a 11-point numeric rating scale (NRS).

Exclusion Criteria:

• chronic pain syndrome other than CP;
• episode of acute pancreatitis within 2 months of enrollment;
• endoscopic therapy including ERCP, EUS Guided Celiac Plexus Block or pancreatic surgery < 6 months prior to enrollment;
• active illicit drug use (excludes marijuana use);
• American Society of Anesthesiologists classification > 3;
• immune-mediated pancreatitis or associated pancreatic neoplasms
• Major neurological disease such as stroke, uncontrolled epilepsy, dementia
• Diagnosis of schizophrenia
• Chronic benzodiazepine use. Use of short acting benzodiazepine on as needed basis is acceptable if participant is able to hold benzodiazepine prior to EEG recording.
• Pregnancy

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Brief Pain Inventory (BPI) Score at Month 3 Post-Operation	BPI is a 9-item assessment of pain. Each item is rated on a Likert scale from 0 (No Pain) to 10 (Pain as bad as you can imagine). The total score is the sum of responses and ranges from 0-90; higher scores indicate greater pain.	Baseline, Month 3 Post-Operation
Secondary	Change from Baseline in BPI Score at Month 6 Post-Operation	BPI is a 9-item assessment of pain. Each item is rated on a Likert scale from 0 (No Pain) to 10 (Pain as bad as you can imagine). The total score is the sum of responses and ranges from 0-90; higher scores indicate greater pain.	Baseline, Month 6 Post-Operation
Secondary	Change from Baseline in BPI Score at Month 12 Post-Operation	BPI is a 9-item assessment of pain. Each item is rated on a Likert scale from 0 (No Pain) to 10 (Pain as bad as you can imagine). The total score is the sum of responses and ranges from 0-90; higher scores indicate greater pain.	Baseline, Month 12 Post-Operation
Secondary	Change from Baseline in BPI Score at Month 18 Post-Operation	BPI is a 9-item assessment of pain. Each item is rated on a Likert scale from 0 (No Pain) to 10 (Pain as bad as you can imagine). The total score is the sum of responses and ranges from 0-90; higher scores indicate greater pain.	Baseline, Month 18 Post-Operation
Secondary	Change from Baseline in Patient Reported Outcome System (PROMIS) - Physical Function - Short Form 6b Score at Month 3 Post-Operation	The PROMIS Physical Function Short Form 6b comprises 6 questions assessing general physical function. Each item is rated on a Likert scale from 1 (Unable to do) to 5 (Without any difficulty). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater physical function.	Baseline, Month 3 Post-Operation
Secondary	Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 6 Post-Operation	The PROMIS Physical Function Short Form 6b comprises 6 questions assessing general physical function. Each item is rated on a Likert scale from 1 (Unable to do) to 5 (Without any difficulty). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater physical function.	Baseline, Month 6 Post-Operation
Secondary	Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 12 Post-Operation	The PROMIS Physical Function Short Form 6b comprises 6 questions assessing general physical function. Each item is rated on a Likert scale from 1 (Unable to do) to 5 (Without any difficulty). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater physical function.	Baseline, Month 12 Post-Operation
Secondary	Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 18 Post-Operation	The PROMIS Physical Function Short Form 6b comprises 6 questions assessing general physical function. Each item is rated on a Likert scale from 1 (Unable to do) to 5 (Without any difficulty). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater physical function.	Baseline, Month 18 Post-Operation
Secondary	Number of Participants who use Opioids at Baseline		Baseline
Secondary	Number of Participants who use Opioids at Month 3		Month 3
Secondary	Number of Participants who use Opioids at Month 6		Month 6
Secondary	Number of Participants who use Opioids at Month 12		Month 12
Secondary	Number of Participants who use Opioids at Month 18		Month 18
Secondary	Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 3 Post-Procedure	The PROMIS Depression - Short Form 4a is a 4-item assessment of symptoms of depression in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of depressive symptoms.	Baseline, Month 3 Post-Procedure
Secondary	Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 6 Post-Procedure	The PROMIS Depression - Short Form 4a is a 4-item assessment of symptoms of depression in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of depressive symptoms.	Baseline, Month 6 Post-Procedure
Secondary	Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 12 Post-Procedure	The PROMIS Depression - Short Form 4a is a 4-item assessment of symptoms of depression in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of depressive symptoms.	Baseline, Month 12 Post-Procedure
Secondary	Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 18 Post-Procedure	The PROMIS Depression - Short Form 4a is a 4-item assessment of symptoms of depression in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of depressive symptoms.	Baseline, Month 18 Post-Procedure
Secondary	Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 3 Post-Procedure	The PROMIS Anxiety- Short Form 4a is a 4-item assessment of symptoms of anxiety in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of anxiety.	Baseline, Month 3 Post-Procedure
Secondary	Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 6 Post-Procedure	The PROMIS Anxiety- Short Form 4a is a 4-item assessment of symptoms of anxiety in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of anxiety.	Baseline, Month 6 Post-Procedure
Secondary	Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 12 Post-Procedure	The PROMIS Anxiety- Short Form 4a is a 4-item assessment of symptoms of anxiety in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of anxiety.	Baseline, Month 12 Post-Procedure
Secondary	Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 18 Post-Procedure	The PROMIS Anxiety- Short Form 4a is a 4-item assessment of symptoms of anxiety in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of anxiety.	Baseline, Month 18 Post-Procedure
Secondary	Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 3 Post-Procedure	The PROMIS Neuropathic Pain Quality 5a is a 5-item assessment of symptoms of neuropathic pain in the past 7 days. Items are ranked on a Likert scale from 1 (not at all) to 5 (very much). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of neuropathic pain.	Baseline, Month 3 Post-Procedure
Secondary	Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 6 Post-Procedure	The PROMIS Neuropathic Pain Quality 5a is a 5-item assessment of symptoms of neuropathic pain in the past 7 days. Items are ranked on a Likert scale from 1 (not at all) to 5 (very much). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of neuropathic pain.	Baseline, Month 6 Post-Procedure
Secondary	Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 12 Post-Procedure	The PROMIS Neuropathic Pain Quality 5a is a 5-item assessment of symptoms of neuropathic pain in the past 7 days. Items are ranked on a Likert scale from 1 (not at all) to 5 (very much). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of neuropathic pain.	Baseline, Month 12 Post-Procedure
Secondary	Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 18 Post-Procedure	The PROMIS Neuropathic Pain Quality 5a is a 5-item assessment of symptoms of neuropathic pain in the past 7 days. Items are ranked on a Likert scale from 1 (not at all) to 5 (very much). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of neuropathic pain.	Baseline, Month 18 Post-Procedure
Secondary	Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 3 Post-Procedure	The PROMIS Sleep Disturbance - Short Form 6a is a 6-item assessment of sleep disturbance in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of sleep disturbance.	Baseline, Month 3 Post-Procedure
Secondary	Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 6 Post-Procedure	The PROMIS Sleep Disturbance - Short Form 6a is a 6-item assessment of sleep disturbance in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of sleep disturbance.	Baseline, Month 6 Post-Procedure
Secondary	Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 12 Post-Procedure	The PROMIS Sleep Disturbance - Short Form 6a is a 6-item assessment of sleep disturbance in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of sleep disturbance.	Baseline, Month 12 Post-Procedure
Secondary	Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 18 Post-Procedure	The PROMIS Sleep Disturbance - Short Form 6a is a 6-item assessment of sleep disturbance in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of sleep disturbance.	Baseline, Month 18 Post-Procedure
Secondary	Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 3 Post-Procedure	The PROMIS Fatigue - Short Form 6a is a 6-item assessment of fatigue in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of fatigue.	Baseline, Month 3 Post-Procedure
Secondary	Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 6 Post-Procedure	The PROMIS Fatigue - Short Form 6a is a 6-item assessment of fatigue in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of fatigue.	Baseline, Month 6 Post-Procedure
Secondary	Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 12 Post-Procedure	The PROMIS Fatigue - Short Form 6a is a 6-item assessment of fatigue in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of fatigue.	Baseline, Month 12 Post-Procedure
Secondary	Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 18 Post-Procedure	The PROMIS Fatigue - Short Form 6a is a 6-item assessment of fatigue in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of fatigue.	Baseline, Month 18 Post-Procedure
Secondary	Change from Baseline in Pain Catastrophizing Scale (PCS) Score at Month 3 Post-Procedure	The PCS is a 13-item assessment of the prevalence of thoughts and feelings associated with pain. Each item is rated on a Likert scale from 0 (not at all) to 4 (all the time). The total score is the sum of responses and ranges from 0 to 52; higher scores indicate greater pain catastrophizing.	Baseline, Month 3 Post-Procedure
Secondary	Change from Baseline in PCS Score at Month 6 Post-Procedure	The PCS is a 13-item assessment of the prevalence of thoughts and feelings associated with pain. Each item is rated on a Likert scale from 0 (not at all) to 4 (all the time). The total score is the sum of responses and ranges from 0 to 52; higher scores indicate greater pain catastrophizing.	Baseline, Month 6 Post-Procedure
Secondary	Change from Baseline in PCS Score at Month 12 Post-Procedure	The PCS is a 13-item assessment of the prevalence of thoughts and feelings associated with pain. Each item is rated on a Likert scale from 0 (not at all) to 4 (all the time). The total score is the sum of responses and ranges from 0 to 52; higher scores indicate greater pain catastrophizing.	Baseline, Month 12 Post-Procedure
Secondary	Change from Baseline in PCS Score at Month 18 Post-Procedure	The PCS is a 13-item assessment of the prevalence of thoughts and feelings associated with pain. Each item is rated on a Likert scale from 0 (not at all) to 4 (all the time). The total score is the sum of responses and ranges from 0 to 52; higher scores indicate greater pain catastrophizing.	Baseline, Month 18 Post-Procedure
Secondary	Change from Baseline in Sleep Duration at Month 3 Post-Procedure		Baseline, Month 3 Post-Procedure
Secondary	Change from Baseline in Sleep Duration at Month 6 Post-Procedure		Baseline, Month 6 Post-Procedure
Secondary	Change from Baseline in Sleep Duration at Month 12 Post-Procedure		Baseline, Month 12 Post-Procedure
Secondary	Change from Baseline in Sleep Duration at Month 18 Post-Procedure		Baseline, Month 18 Post-Procedure
Secondary	Change from Baseline in Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Score at Month 3 Post-Procedure	TAPS consists of a combined screening component (TAPS-1) followed by a brief followed by a brief assessment (TAPS-2) for those who screen positive. Scores on these questions generate a risk level per substance endorsed, based on a range of possible scores per substance. Scores range from 0-4; higher scores indicate a higher likelihood of problematic substance use.	Baseline, Month 3 Post-Procedure
Secondary	Change from Baseline in TAPS Score at Month 6 Post-Procedure	TAPS consists of a combined screening component (TAPS-1) followed by a brief followed by a brief assessment (TAPS-2) for those who screen positive. Scores on these questions generate a risk level per substance endorsed, based on a range of possible scores per substance. Scores range from 0-4; higher scores indicate a higher likelihood of problematic substance use.	Baseline, Month 6 Post-Procedure
Secondary	Change from Baseline in TAPS Score at Month 12 Post-Procedure	TAPS consists of a combined screening component (TAPS-1) followed by a brief followed by a brief assessment (TAPS-2) for those who screen positive. Scores on these questions generate a risk level per substance endorsed, based on a range of possible scores per substance. Scores range from 0-4; higher scores indicate a higher likelihood of problematic substance use.	Baseline, Month 12 Post-Procedure
Secondary	Change from Baseline in TAPS Score at Month 18 Post-Procedure	TAPS consists of a combined screening component (TAPS-1) followed by a brief followed by a brief assessment (TAPS-2) for those who screen positive. Scores on these questions generate a risk level per substance endorsed, based on a range of possible scores per substance. Scores range from 0-4; higher scores indicate a higher likelihood of problematic substance use.	Baseline, Month 18 Post-Procedure
Secondary	Change from Baseline in Patient Global Impression of Change (PGIC) Score at Month 3 Post-Procedure	PGIC is a 1-item assessment of patient's perception of the change in activity limitation, symptoms, emotions and overall quality of life related to their condition since beginning treatment. The item is rated on a scale from 1 (no change) to 7 (a great deal better). The final score is the numerical rating; higher scores indicate greater change.	Baseline, Month 3 Post-Procedure
Secondary	Change from Baseline in PGIC Score at Month 6 Post-Procedure	PGIC is a 1-item assessment of patient's perception of the change in activity limitation, symptoms, emotions and overall quality of life related to their condition since beginning treatment. The item is rated on a scale from 1 (no change) to 7 (a great deal better). The final score is the numerical rating; higher scores indicate greater change.	Baseline, Month 6 Post-Procedure
Secondary	Change from Baseline in PGIC Score at Month 12 Post-Procedure	PGIC is a 1-item assessment of patient's perception of the change in activity limitation, symptoms, emotions and overall quality of life related to their condition since beginning treatment. The item is rated on a scale from 1 (no change) to 7 (a great deal better). The final score is the numerical rating; higher scores indicate greater change.	Baseline, Month 12 Post-Procedure
Secondary	Change from Baseline in PGIC Score at Month 18 Post-Procedure	PGIC is a 1-item assessment of patient's perception of the change in activity limitation, symptoms, emotions and overall quality of life related to their condition since beginning treatment. The item is rated on a scale from 1 (no change) to 7 (a great deal better). The final score is the numerical rating; higher scores indicate greater change.	Baseline, Month 18 Post-Procedure
Secondary	Change from Baseline in Patient Health Questionnaire-2 (PHQ-2) Score at Month 3 Post-Procedure	PHQ-2 is a 2-item assessment of patient health in the last 2 weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0 to 6; lower scores indicate better health.	Baseline, Month 3 Post-Procedure
Secondary	Change from Baseline in PHQ-2 Score at Month 6 Post-Procedure	PHQ-2 is a 2-item assessment of patient health in the last 2 weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0 to 6; lower scores indicate better health.	Baseline, Month 6 Post-Procedure
Secondary	Change from Baseline in PHQ-2 Score at Month 12 Post-Procedure	PHQ-2 is a 2-item assessment of patient health in the last 2 weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0 to 6; lower scores indicate better health.	Baseline, Month 12 Post-Procedure
Secondary	Change from Baseline in PHQ-2 Score at Month 18 Post-Procedure	PHQ-2 is a 2-item assessment of patient health in the last 2 weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0 to 6; lower scores indicate better health.	Baseline, Month 18 Post-Procedure
Secondary	Change from Baseline in Generalized Anxiety Disorder 2 (GAD-2) Score at Month 3 Post-Procedure	GAD-2 is a 2-item assessment of symptoms of anxiety in the past two weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day).The total score is the sum of responses and ranges from 0-6; higher scores indicate greater symptoms of anxiety.	Baseline, Month 3 Post-Procedure
Secondary	Change from Baseline in GAD-2 Score at Month 6 Post-Procedure	GAD-2 is a 2-item assessment of symptoms of anxiety in the past two weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day).The total score is the sum of responses and ranges from 0-6; higher scores indicate greater symptoms of anxiety.	Baseline, Month 6 Post-Procedure
Secondary	Change from Baseline in GAD-2 Score at Month 12 Post-Procedure	GAD-2 is a 2-item assessment of symptoms of anxiety in the past two weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day).The total score is the sum of responses and ranges from 0-6; higher scores indicate greater symptoms of anxiety.	Baseline, Month 12 Post-Procedure
Secondary	Change from Baseline in GAD-2 Score at Month 18 Post-Procedure	GAD-2 is a 2-item assessment of symptoms of anxiety in the past two weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day).The total score is the sum of responses and ranges from 0-6; higher scores indicate greater symptoms of anxiety.	Baseline, Month 18 Post-Procedure
Secondary	Change from Baseline in Pain, Enjoyment of Life and General Activity (PEG) Scale at Month 3 Post-Procedure	PEG is a 3-item assessment of pain and how it interferes with activities of daily life. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes). The total score is the average of the 3 items and ranges from 0-10; higher scores indicate greater pain interference.	Baseline, Month 3 Post-Procedure
Secondary	Change from Baseline in PEG Scale at Month 6 Post-Procedure	PEG is a 3-item assessment of pain and how it interferes with activities of daily life. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes). The total score is the average of the 3 items and ranges from 0-10; higher scores indicate greater pain interference.	Baseline, Month 6 Post-Procedure
Secondary	Change from Baseline in PEG Scale at Month 12 Post-Procedure	PEG is a 3-item assessment of pain and how it interferes with activities of daily life. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes). The total score is the average of the 3 items and ranges from 0-10; higher scores indicate greater pain interference.	Baseline, Month 12 Post-Procedure
Secondary	Change from Baseline in PEG Scale at Month 18 Post-Procedure	PEG is a 3-item assessment of pain and how it interferes with activities of daily life. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes). The total score is the average of the 3 items and ranges from 0-10; higher scores indicate greater pain interference.	Baseline, Month 18 Post-Procedure